FDA-Drug2025-01-01Class II
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
PD-Rx Pharmaceuticals, Inc.
Hazard
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Sold states
Distributed within US: FL, MS, WI
Affected count
70, 90-count bottles
Manufactured in
727 N Ann Arbor Ave, Oklahoma City, OK, United States
Products
DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0163-2025Don't want to check this manually?
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